Products Liability Law Reporter

The Eighth Circuit Court of Appeals held that the manufacturer of the ParaGard IUD was not liable to a patient whose physician was warned about the IUD’s potential risks.

Stephanie Ideus had the ParaGard T 380A Intrauterine Copper Contraceptive implanted by her physician. When Ideus later tried to have it removed, it was discovered that the IUD had broken apart and that a piece had become embedded in her uterus, necessitating surgery. Ideus sued Teva Pharmaceuticals USA, Inc., and Teva Women’s Health, Inc., alleging breach of the duty to warn. The defense moved for summary judgment, which the court granted on the basis of the learned intermediary doctrine. The plaintiff appealed, arguing that the Nebraska Supreme Court would not apply the learned intermediary doctrine to contraceptive devices.

Affirming, the Eighth Circuit noted that Nebraska requires manufacturers to warn consumers directly about hazards and risks inherent in a product’s design, except for prescription drugs, which are covered by the learned intermediary doctrine. The court found, however, that the state high court has not previously determined whether it would apply the learned intermediary doctrine to products like IUDs.

The court said that Nebraska has adopted The Restatement (Third) of Torts: Products Liability §6(d), which precludes liability for failure to warn against manufacturers of prescription drugs or medical devices that adequately communicate the risks to health care providers, absent a special circumstance warranting a direct warning to a consumer. Citing case law involving a prescription drug, the court said that the rationale underlying §6(d) is that medical professionals are in the best position to determine a product’s potential risks and decide whether a patient should use the product. The court held that by adopting §6(d) and noting the wide acceptance of the learned intermediary doctrine, the Nebraska high court has signaled its preference for the majority rule of applying the learned intermediary doctrine to failure-to-warn cases involving prescription contraceptives.

Accordingly, the court concluded that the defense was entitled to summary judgment where it had fulfilled its duty to warn the plaintiff’s physician about the potential risks of ParaGard.

Citation: Ideus v. Teva Pharms. USA, Inc., 2021 WL 415774 (8th Cir. Feb. 8, 2021).